FDA proposes rules on e-cigarettes

The Food and Drug Administration is seeking to extend its regulatory authority to electronic cigarettes through provisions that would prevent minors from purchasing these products and prohibit e-cigarettes from being sold in vending machines or being passed out as free samples.

The proposed rule, which is being released Thursday, follows sharp criticism by public health advocates and many lawmakers that the agency has delayed action even as many more youth have begun using e-cigarettes. It could be another year before the intended restrictions and protections go into effect, however.

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Commissioner Margaret Hamburg called the rule “a historic moment for the FDA.” During a press briefing Wednesday, she noted that the proposal lays the foundation for further control of e-cigarettes as well as cigars, another currently unregulated tobacco product that also would be covered by the rule.

And Health and Human Services Secretary Kathleen Sebelius said in a statement that it is “the latest step in our efforts to make the next generation tobacco-free.” Recent federal data show that e-cigarette use among middle and high school students has more than doubled since 2011.

Over the past several months, frustrated public health groups and lawmakers have sent dozens of letters to the Obama administration and pushed legislation at both the state and federal level. In the absence of federal regulation, 32 states have passed bans on the sale of e-cigarettes to minors. FDA regulation would not pre-empt those state efforts.

It’s inexcusable that it has taken the FDA and the administration more than three years to issue the deeming regulation,” said Vince Willmore, vice president of communications for the Campaign for Tobacco-Free Kids. “It can’t take another three years before this is finalized.”

“The regulator will finally be doing its job,” Mitch Zeller, director of FDA’s Center for Tobacco Products, acknowledged at the briefing. With no regulation, he said, it’s been “the wild, wild west.”

With U.S. sales now estimated at $1.5 billion annually, e-cigarette companies say they welcome federal regulation. Many have supported bans on sales of their products to minors and say they would like to see the same at the federal level.

“NuMark supports FDA extending the appropriate regulation over all tobacco products, including those containing tobacco-derived nicotine,” said David Sutton, a spokesman for Altria Inc., whose subsidiary NuMark manufactures e-cigarettes. “We think that this comprehensive regulatory framework … can contribute to resolving many of the complex issues” surrounding e-cigarettes.

The proposed rule would give FDA authority over e-cigarettes, cigars, pipe tobacco, nicotine gels, hookah and dissolvables. FDA currently can regulate only cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. A public comment period on the draft language will follow for the next 75 days. There is no set schedule for issuance of a final rule.

Sen. Tom Harkin (D-Iowa), who has long pressed both FDA and the Federal Trade Commission to pursue the industry’s marketing tactics targeting children, said Thursday that he would examine the new proposal closely. “It’s past time for FDA to take action on e-cigarettes and to treat these products as what they are — addictive tobacco products,” Harkin said in a statement.

FDA would include e-cigarettes, cigars and the additional items in several provisions that apply to regulated tobacco products, including age and identification requirements to restrict sales to youth under 18 and prohibitions on free samples and vending machine sales. These provisions would go into effect 30 days after the final rule is released.

Further restrictions, such as required health warning labels, would go into effect two years after the final rule is released. Cigars would bear five warnings, including one about the addictiveness of their nicotine content, Zeller said. E-cigarettes would also come with an addiction warning.

Manufacturers would be required to register with FDA and report their products’ ingredients. Marketing of new products and marketing that makes health claims would require FDA approval.

The proposed rule is likely to be controversial for failing to limit online sales or television advertising. Nor would FDA categorically ban flavoring. Cigars and e-cigarettes come in fruity flavors like peach and cherry that public health advocates say are especially appealing to minors.

Such additional restrictions would require separate rule-making, Hamburg said. In the meantime, the agency is funding research about the potential health risks and benefits of the products, as well as who is using them and how. The jury is still out on the safety of e-cigarettes, which contain liquid nicotine that is inhaled as a vapor. Some people argue they are a helpful tool for individuals trying to quit smoking traditional cigarettes. Others point to research that suggests they’re no less carcinogenic.

The continuation of online sales is sure to draw public health groups’ ire. Enforcement of restrictions on online sales to minors will be a “huge challenge,” Hamburg said.

Manufacturers of the newly deemed tobacco products will have two years after the final rule is released to submit an application to keep their products on the market. During that period, even as an application is pending, they can continue to sell their products. But after two years, new products must be approved by FDA before going to market.

“By coming forward now with this proposed rule, it starts a process where industry recognizes that regulation is in its future,” Hamburg said. Officials said the agency is confident that should manufacturers pursue litigation, there will be sufficient science-based evidence to support the final rule.

FDA is specifically requesting public comment on whether all cigars should be regulated. Zeller said some outside parties have suggested that “premium cigars,” which include cigars made from whole tobacco leaves and those with no added flavors, are used differently and should therefore be exempted.

“It won’t be the beginning of the end of the regulatory process,” Gregg Haifley, director of federal relations at the American Cancer Society Cancer Action Network, said of the proposed rule. “It will be the end of the beginning of the regulatory process.”

Hamburg would not give a timeline for finalizing the rule. “What I can tell you is that we seek a sense of urgency to finalize the deeming rule,” she said during a media call Thursday. “We are very very eager to move forward.”